GANX Gain Therapeutics Inc.

8
-0.2  -2%
Previous Close 8.2
Open 8.36
52 Week Low 8.2807
52 Week High 17.93
Market Cap $95,013,120
Shares 11,876,640
Float 10,783,957
Enterprise Value $52,016,403
Volume 32,104
Av. Daily Volume 28,404
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Latest News

  1. BETHESDA, Md., June 10, 2021 (GLOBE NEWSWIRE) -- Gain Therapeutics, Inc. (NASDAQ:GANX) ("Gain"), a biotechnology company focused on redefining drug discovery by identifying and optimizing allosteric binding sites that have never before been targeted, today announced the publication of two PCT patents. PCT/IB2020/061158 and PCT/IB2020/0611156 are directed at compounds targeting misfolded beta-​glucocerebrosidase (GBA) and galactosylceramidase (GALC) respectively, addressing central nervous system (CNS) and demyelinating disorders such as Parkinson's Disease, Lewy body dementia and Alzheimer's.

    "This is a pivotal milestone for Gain Therapeutics as these two patents highlight the association between the approach to treating rare diseases, such…

    BETHESDA, Md., June 10, 2021 (GLOBE NEWSWIRE) -- Gain Therapeutics, Inc. (NASDAQ:GANX) ("Gain"), a biotechnology company focused on redefining drug discovery by identifying and optimizing allosteric binding sites that have never before been targeted, today announced the publication of two PCT patents. PCT/IB2020/061158 and PCT/IB2020/0611156 are directed at compounds targeting misfolded beta-​glucocerebrosidase (GBA) and galactosylceramidase (GALC) respectively, addressing central nervous system (CNS) and demyelinating disorders such as Parkinson's Disease, Lewy body dementia and Alzheimer's.

    "This is a pivotal milestone for Gain Therapeutics as these two patents highlight the association between the approach to treating rare diseases, such as Gaucher Disease and Krabbe Disease, and the approach to treating more widely prevalent and growing disease states like Parkinson's Disease and Multiple Sclerosis," said Eric Richman, Chief Executive Officer of Gain. "The two issued patents reflect our focus and commitment to developing first in class therapies for these CNS and lysosomal storage diseases, and we are excited to strengthen our intellectual property and advance our potential to treat patients with these devastating diseases."

    PCT/IB2020/061158 covers compounds and therapeutic uses of conditions associated with the alteration of Beta-glucocerebrosidase (GBA). These conditions include Gaucher Disease, Parkinson's Disease, and other Lewy body disorders including Alzheimer's Disease and amyotrophic lateral sclerosis (ALS).

    PCT/IB2020/0611156 covers compounds and therapeutic uses of conditions associated with the alteration of galactosylceramidase (GALC). These conditions include lysosomal storage diseases and other demyelinating diseases, such as Krabbe Disease, Lewy body dementia, Multiple Sclerosis, and peripheral neuropathy.

    About Gain Therapeutics, Inc.

    Gain Therapeutics, Inc. is redefining drug discovery with its SEE-Tx™ target identification platform. By identifying and optimizing allosteric binding sites that have never before been targeted, Gain is unlocking new treatment options for difficult-to-treat disorders characterized by protein misfolding. Gain was established in 2017 with the support of its founders and institutional investors. It has been awarded funding support from The Michael J. Fox Foundation for Parkinson's Research (MJFF) and The Silverstein Foundation for Parkinson's with GBA, as well as from the Eurostars-2 joint program with co-funding from the European Union Horizon 2020 research and Innosuisse. In July 2020, Gain Therapeutics, Inc. completed a share exchange with Gain Therapeutics, SA, a Swiss corporation, whereby GT Gain Therapeutics SA became a wholly owned subsidiary of Gain Therapeutics, Inc.

    For more information, visit https://www.gaintherapeutics.com/.

    Forward-Looking Statements

    Any statements in this release that are not historical facts may be considered to be "forward-looking statements." Forward-looking statements are based on management's current expectations and are subject to risks and uncertainties which may cause results to differ materially and adversely from the statements contained herein. Such statements include, but are not limited to, statements regarding the market opportunity for Gain's product candidates; and the business strategies and development plans of Gain. Some of the potential risks and uncertainties that could cause actual results to differ from those expected include Gain's ability to: make commercially available its products and technologies in a timely manner or at all; enter into other strategic alliances, including arrangements for the development and distribution of its products; obtain intellectual property protection for its assets; accurately estimate its expenses and cash burn and raise additional funds when necessary. Undue reliance should not be placed on forward-looking statements, which speak only as of the date they are made. Except as required by law, Gain does not undertake any obligation to update any forward-looking statements to reflect new information, events or circumstances after the date they are made, or to reflect the occurrence of unanticipated events.

    Investor Contact:

    Daniel Ferry

    LifeSci Advisors

    +1 617-430-7576

    Media Contact:

    Joleen Schultz

    Joleen Schultz & Associates

    +1 760-271-8150

     



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  2. BETHESDA, Md., May 27, 2021 (GLOBE NEWSWIRE) -- Gain Therapeutics, Inc. (NASDAQ:GANX) ("Gain"), a biotechnology company focused on redefining drug discovery by identifying and optimizing allosteric binding sites that have never before been targeted, today announced that Eric Richman, Chief Executive Officer of Gain Therapeutics, will present a corporate overview at the Jefferies Virtual Healthcare Conference being held on June 1 – 4.

    Jefferies Virtual Healthcare Conference
    Date:Tuesday, June 1ST
    Time:3:00 to 3:25 p.m. ET
    Presenter:Eric Richman, Chief Executive Officer
    Webcast:https://wsw.com/webcast/jeff174/ganx/1851714 or
     at the Company's News & Events section of their website (click here)

    replay of the session will be on the Gain Therapeutics…

    BETHESDA, Md., May 27, 2021 (GLOBE NEWSWIRE) -- Gain Therapeutics, Inc. (NASDAQ:GANX) ("Gain"), a biotechnology company focused on redefining drug discovery by identifying and optimizing allosteric binding sites that have never before been targeted, today announced that Eric Richman, Chief Executive Officer of Gain Therapeutics, will present a corporate overview at the Jefferies Virtual Healthcare Conference being held on June 1 – 4.

    Jefferies Virtual Healthcare Conference

    Date:Tuesday, June 1ST
    Time:3:00 to 3:25 p.m. ET
    Presenter:Eric Richman, Chief Executive Officer
    Webcast:https://wsw.com/webcast/jeff174/ganx/1851714 or
     at the Company's News & Events section of their website (click here)

    replay of the session will be on the Gain Therapeutics website for approximately 30-days following the conference.

    Please contact your Jefferies representative to schedule virtual one-on-one meetings with Gain's management team during the conference.

    About Jefferies Virtual Healthcare Conference

    The annual June conference will be held virtually with video fireside chats, presentations, keynotes, panels and 1x1/small group meetings via Zoom. This virtual gathering of over 400 public & private healthcare companies and 3,000 leading executives, institutional investors, private equity investors & VCs will address near- and long-term investment opportunities and discuss the current trends driving healthcare in the U.S. and internationally.

    For further information, please visit: www.Jefferies.com

    About Gain Therapeutics, Inc.

    Gain Therapeutics, Inc. is redefining drug discovery with its SEE-Tx™ target identification platform. By identifying and optimizing allosteric binding sites that have never before been targeted, Gain is unlocking new treatment options for difficult-to-treat disorders characterized by protein misfolding. Gain was established in 2017 with the support of its founders and institutional investors. It has been awarded funding support from The Michael J. Fox Foundation for Parkinson's Research (MJFF) and The Silverstein Foundation for Parkinson's with GBA, as well as from the Eurostars-2 joint program with co-funding from the European Union Horizon 2020 research and Innosuisse. In July 2020, Gain Therapeutics, Inc. completed a share exchange with Gain Therapeutics, SA, a Swiss corporation, whereby GT Gain Therapeutics SA became a wholly owned subsidiary of Gain Therapeutics, Inc.

    For more information, visit https://www.gaintherapeutics.com/.

    Forward-Looking Statements

    Any statements in this release that are not historical facts may be considered to be "forward-looking statements." Forward-looking statements are based on management's current expectations and are subject to risks and uncertainties which may cause results to differ materially and adversely from the statements contained herein. Such statements include, but are not limited to, statements regarding the market opportunity for Gain's product candidates; and the business strategies and development plans of Gain. Some of the potential risks and uncertainties that could cause actual results to differ from those expected include Gain's ability to: make commercially available its products and technologies in a timely manner or at all; enter into other strategic alliances, including arrangements for the development and distribution of its products; obtain intellectual property protection for its assets; accurately estimate its expenses and cash burn and raise additional funds when necessary. Undue reliance should not be placed on forward-looking statements, which speak only as of the date they are made. Except as required by law, Gain does not undertake any obligation to update any forward-looking statements to reflect new information, events or circumstances after the date they are made, or to reflect the occurrence of unanticipated events.

    Investor Contact:

    Daniel Ferry

    LifeSci Advisors

    +1 617-430-7576

    Media Contact:

    Madeline Joanis

    LifeSci Communications

    +1 646-751-4366



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  3. BETHESDA, Md., May 17, 2021 (GLOBE NEWSWIRE) -- Gain Therapeutics, Inc. (NASDAQ:GANX) ("Gain"), a biotechnology company focused on redefining drug discovery by identifying and optimizing allosteric binding sites that have never before been targeted, today announced that Eric Richman, Chief Executive Officer of Gain Therapeutics, will present a corporate overview at the 2021 RBC Capital Markets Global Healthcare Virtual Conference and at the Oppenheimer Rare & Orphan Disease Summit, both taking place in May.

    2021 RBC Capital Markets Global Healthcare Virtual Conference

    Date: Wednesday, May 19TH
    Time: 9:10 a.m. ET
    Location: Webcast Linkor at the company's website (click here)

    Oppenheimer Rare & Orphan Disease Summit

    Date: Friday, May 21ST
    Time:

    BETHESDA, Md., May 17, 2021 (GLOBE NEWSWIRE) -- Gain Therapeutics, Inc. (NASDAQ:GANX) ("Gain"), a biotechnology company focused on redefining drug discovery by identifying and optimizing allosteric binding sites that have never before been targeted, today announced that Eric Richman, Chief Executive Officer of Gain Therapeutics, will present a corporate overview at the 2021 RBC Capital Markets Global Healthcare Virtual Conference and at the Oppenheimer Rare & Orphan Disease Summit, both taking place in May.

    2021 RBC Capital Markets Global Healthcare Virtual Conference

    Date: Wednesday, May 19TH
    Time: 9:10 a.m. ET
    Location: Webcast Linkor at the company's website (click here)

    Oppenheimer Rare & Orphan Disease Summit

    Date: Friday, May 21ST
    Time: 8:15 a.m. ET
    Location: Webcast Linkor at the company's website (click here)

    About Gain Therapeutics, Inc.

    Gain Therapeutics, Inc. is redefining drug discovery with its SEE-Tx™ target identification platform. By identifying and optimizing allosteric binding sites that have never before been targeted, Gain is unlocking new treatment options for difficult-to-treat disorders characterized by protein misfolding. Gain was established in 2017 with the support of its founders and institutional investors. It has been awarded funding support from The Michael J. Fox Foundation for Parkinson's Research (MJFF) and The Silverstein Foundation for Parkinson's with GBA, as well as from the Eurostars-2 joint program with co-funding from the European Union Horizon 2020 research and Innosuisse. In July 2020, Gain Therapeutics, Inc. completed a share exchange with Gain Therapeutics, SA, a Swiss corporation, whereby GT Gain Therapeutics SA became a wholly owned subsidiary of Gain Therapeutics, Inc.

    For more information, visit https://www.gaintherapeutics.com/

    Forward-Looking Statements

    Any statements in this release that are not historical facts may be considered to be "forward-looking statements." Forward-looking statements are based on management's current expectations and are subject to risks and uncertainties which may cause results to differ materially and adversely from the statements contained herein. Such statements include, but are not limited to, statements regarding the market opportunity for Gain's product candidates; and the business strategies and development plans of Gain. Some of the potential risks and uncertainties that could cause actual results to differ from those expected include Gain's ability to: make commercially available its products and technologies in a timely manner or at all; enter into other strategic alliances, including arrangements for the development and distribution of its products; obtain intellectual property protection for its assets; accurately estimate its expenses and cash burn and raise additional funds when necessary. Undue reliance should not be placed on forward-looking statements, which speak only as of the date they are made. Except as required by law, Gain does not undertake any obligation to update any forward-looking statements to reflect new information, events or circumstances after the date they are made, or to reflect the occurrence of unanticipated events.

    Investor Contact:

    Daniel Ferry

    LifeSci Advisors

    +1 617-430-7576

    Media Contact:

    Madeline Joanis

    LifeSci Communications

    +1 646-751-4366



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  4. Completed successful initial public offering and raised $46 million in gross proceeds
    ---
    Appointed four new independent board of directors to strengthen leadership team
    ---
    Signed a multi-target collaboration agreement with Zentalis Pharmaceuticals (NASDAQ:ZNTL) to discover new product candidates for the treatment of cancer
    ---
    Presented positive pre-clinical lysosomal storage target data at annual WorldSymposium™
    ---
    Expect to complete proof of concept animal studies and begin IND-enabling trials in the second half of 2021

    BETHESDA, Md., May 10, 2021 (GLOBE NEWSWIRE) -- Gain Therapeutics, Inc. (NASDAQ:GANX) ("Gain", or the "Company"), a biotechnology company focused on redefining drug discovery by identifying allosteric sites that have never…

    Completed successful initial public offering and raised $46 million in gross proceeds

    ---

    Appointed four new independent board of directors to strengthen leadership team

    ---

    Signed a multi-target collaboration agreement with Zentalis Pharmaceuticals (NASDAQ:ZNTL) to discover new product candidates for the treatment of cancer

    ---

    Presented positive pre-clinical lysosomal storage target data at annual WorldSymposium™

    ---

    Expect to complete proof of concept animal studies and begin IND-enabling trials in the second half of 2021

    BETHESDA, Md., May 10, 2021 (GLOBE NEWSWIRE) -- Gain Therapeutics, Inc. (NASDAQ:GANX) ("Gain", or the "Company"), a biotechnology company focused on redefining drug discovery by identifying allosteric sites that have never been targeted previously and discovering molecules that can bind stabilize and restore functional activity to misfolded enzymes, today announced its financial results as of and for the first quarter ended March 31, 2021 and provided a corporate update.

    "We were thrilled to complete our IPO in March on the Nasdaq Global Market Exchange," stated Sal Calabrese, Chief Financial Officer of Gain. "The Company now has sufficient financial resources to fund its research and development programs for the foreseeable future. The recent addition of four deeply talented and experienced independent board members provides us with a seasoned leadership team that can help advance the Company towards a clinical stage biopharmaceutical organization."

    Eric Richman, Chief Executive Officer of Gain, added, "We look forward to a very active 2021 and plan to meet several important milestones that will help us advance our SEE-Tx supercomputing platform technology to identify novel allosteric binding sites on misfolded proteins. Our lead pipeline candidates in lysosomal storage and CNS diseases are currently completing animal proof-of-concept studies, and we anticipate moving these into IND-enabling trials towards the end of 2021. We are confident that our Company is on the right path to achieve our mission in redefining drug discovery and develop novel therapies for devastating conditions with significant unmet medical need."

    Business and Recent Developments

    • Multi-target collaboration agreement. In April 2021, the Company announced a multi-target collaboration agreement with Zentalis Pharmaceuticals (NASDAQ:ZNTL) to discover new product candidates for the treatment of cancer. Gain will use its proprietary SEE-Tx computational platform technology to identify new sites on target proteins for potential use in oncology.

       
    • Presentation of data at the International Association of Parkinsonism and Related Disorders 2021 World Congress. In April 2021, the Company announced the presentation of a poster at the International Association of Parkinsonism and Related Disorders (IAPRD) 2021 World Congress being held virtually May 1-4, 2021. The poster highlights data demonstrating the potential of the Company's structurally targeted allosteric regulators (STARs) to restore relevant biological function in vitro and improve motor deficits in an in vivo model of Parkinson's disease.

       
    • Completed Successful IPO. In March 2021, the Company completed an oversubscribed initial public offering (IPO) of 4,181,818 shares of common stock at a public offering price of $11.00 per share, including the full exercise by the underwriters of their overallotment option to purchase 545,454 additional shares of common stock. Gain Therapeutics, Inc received gross proceeds of approximately $46 million in the offering. This financing strengthened the Company's balance sheet it with significant funding to advance its therapeutics programs and pipeline expansion.



    • Presented pre-clinical data at the 17th Annual WorldSymposium. In February 2021, the Company presented positive pre-clinical data supportive of in vitro engagement for Gaucher disease, GM1 gangliosidosis, and Morquio B programs at the 17th Annual WorldSymposium™.

       
    • Appointed new members to the board of directors with deep financial, clinical development and regulatory experience. In February 2021, the Company strengthened the leadership team with the appointment of four industry leaders to the Company's Board of Directors. Dov Goldstein, M.D., Gwen Melincoff, Claude Nicaise, M.D., and Hans Peter Hasler.

    Financial Results

    For the first quarter ended March 31, 2021, compared to same period of 2020:

    • Research and development expenses were $1,422 thousand compared to $417 thousand.
    • General and administrative expenses were $1,051 thousand compared to $102 thousand.
    • Total operating expenses increased to $2,472 thousand compared to $519 thousand.
    • Net loss was $2,450 thousand compared to $584 thousand.
    • Basic and diluted net loss per share was $0.50, compared to basic and diluted net loss per share of $0.29.

    Cash and cash equivalents were $46.59 million as of March 31, 2021 compared to $7.49 million at December 31, 2020. The increase was primarily the result of the completion of the Company's initial public offering, from which the Company received aggregate net proceeds of $42.6 million.

    Gain Therapeutics, Inc. was incorporated under the laws of the state of Delaware (U.S.) on June 26, 2020. On July 20, 2020, the Company consummated a Corporate Reorganization pursuant to which all of the issued and outstanding common and preferred stock of GT Gain Therapeutics SA, a Swiss company formed in 2017, were exchanged for common stock or preferred stock, as applicable, of Gain Therapeutics, Inc. For periods and at dates prior to the Corporate Reorganization, the consolidated financial statements were prepared based on the historical financial statements of GT Gain Therapeutics SA.

    Operating Results

    The Company incurred research and development expenses of $1,422 thousand for the three-month period ended March 31, 2021 compared to $417 thousand for the same period of 2020, an increase of $1,005 thousand. The increase in research and development expenses was primarily attributable to increases in outside services as we continue to expand our research and development activities, including external collaborations, chemical synthesis, toxicology studies, in vitro ADME and model studies, and in vivo. pharmacology and pharmacokinetic studies, as well as increases in payroll, payroll-related expenses and stock-based compensation.

    General and administrative expenses were $1,051 thousand for the three-month period ended March 31, 2021 compared to $102 thousand for the same period of 2020, an increase of $949 thousand. The increase is primarily due to increases in personnel-related costs, including stock based compensation, as a result of senior management hires, increase in expenses for legal fees relating to patent and corporate matters, professional fees for accounting, professional services and investor relations as we continue to expand our business and build management infrastructure.

    As a result of the above net loss was $2,450 thousand for the three-month period ended March 31, 2021, compared to $584 thousand for the same period of 2020. The increase in net loss was due to increased research and development expenses, as well as an increase in general and administrative expenses primarily related to investments in the Company's infrastructure as a publicly traded company.

    About Gain Therapeutics, Inc.

    Gain Therapeutics, Inc. is redefining drug discovery with its SEE-Tx™ target identification platform. By identifying and optimizing allosteric binding sites that have never before been targeted, Gain is unlocking new treatment options for difficult-to-treat disorders characterized by protein misfolding. Gain was established in 2017 with the support of its founders and institutional investors. It has been awarded funding support from The Michael J. Fox Foundation for Parkinson's Research (MJFF) and The Silverstein Foundation for Parkinson's with GBA, as well as from the Eurostars-2 joint program with co-funding from the European Union Horizon 2020 research and Innosuisse. In July 2020, Gain Therapeutics, Inc. completed a share exchange with Gain Therapeutics, SA, a Swiss corporation, whereby GT Gain Therapeutics SA became a wholly owned subsidiary of Gain Therapeutics, Inc.

    Cautionary Note Regarding Forward-Looking Statements

    This press release contains "forward-looking statements." In some cases, you can identify these statements by forward-looking words such as "may," "might," "will," "should," "expect," "plan," "anticipate," "believe," "estimate," "predict," "potential" or "continue," the negative of these terms and other comparable terminology. These statements are not historical facts but instead represent the Company's belief regarding future results, many of which, by their nature, are inherently uncertain and outside the Company's control. It is possible that actual results, including with respect to any financial forecast or the possibility of any future regulatory approval or filing, may differ materially from those anticipated in these forward-looking statements. For a discussion of some of the risks and important factors that could affect future results, see the discussion in our prospectus filed with the Securities and Exchange Commission under the caption "Risk Factors."



    Gain Therapeutics, Inc.

    CONSOLIDATED BALANCE SHEETS (unaudited)

     March 31,

    2021
     December 31,

    2020
    Assets     
    Current assets:     
    Cash and cash equivalents$46,593,604  $7,492,910 
    Restricted cash 11,129   11,371 
    Accounts receivable 4,486   8,548 
    Prepaid expenses and other current assets 774,809   257,011 
    Deferred offering costs -   1,217,988 
    Total current assets$47,384,028  $8,987,828 
          
    Non-current assets:     
    Property and equipment, net 54,717   29,633 
    Operating lease - right of use assets 499,017   523,080 
    Restricted cash 31,554   - 
    Long-term deposits 12,008   12,152 
    Other non-current assets 59,740   51,665 
    Total non-current assets$657,036  $616,530 
    Total Assets$48,041,064  $9,604,358 
            
    Current liabilities:     
    Accounts payable 881,753   961,516 
    Operating lease liability - current 121,419   122,756 
    Other current liabilities 1,096,334   767,380 
    Tax provision 4,526   1,070 
    Deferred income 178,418   239,483 
    Loans - short term 44,287   22,626 
    Total current liabilities$2,326,737  $2,114,831 
          
    Non-current liabilities:     
    Defined benefit pension plan 194,465   171,558 
    Operating lease liability - non-current 377,598   400,324 
    Loans - long term 678,255   715,656 
    Total non-current liabilities$1,250,318  $1,287,538 
          
    Stockholders' equity     
    Series A Preferred Stock: $0.0001 par value, nil and 1,185,879 shares issued and outstanding as of March 31, 2021 and December 31, 2020, respectively -   118 
    Series B Preferred Stock: $0.0001 par value, nil and 2,965,600 shares issued and outstanding as of March 31, 2021 and December 31, 2020, respectively -   297 
    Common Stock, $0.0001 par value: 11,876,460 and 7,694,642 issued and outstanding as of March 31, 2021 and December 31, 2020, respectively 1,188   354 
    Additional paid-in capital 54,104,982   13,388,771 
    Accumulated other comprehensive loss (156,861)  (152,698)
    Accumulated deficit (7,034,853)  (3,457,171)
    Loss of the period (2,450.447)  (3,577,682)
    Total Stockholders' equity$44,464,009  $6,201,989 
    Total Liabilities and Stockholders' equity$48,041,064  $9,604,358 



    Gain Therapeutics, Inc

    CONSOLIDATED STATEMENTS OF OPERATIONS

    (unaudited)

     For Three Months Ended March 31,
      2021  2020
    Revenues:     
    Other income 5,269  6,673
    Total revenues $5,269 $6,673
          
    Operating expenses:     
    Research and development (1,421,509)  (417,259)
    General and administrative (1,050,675)  (101,674)
    Total operating expenses (2,472,184)  (518,933)
          
    Loss from operations$(2,466,915) $(512,260)
          
    Other income (expense):     
    Interest income/(expenses), net 1,408  (1,747)
    Foreign exchange gain/(loss), net 18,539  (68,914)
    Loss before income tax$(2,446,968) $(582,921)
          
    Income tax (3,479)  (1,347)
          
    Net Loss$(2,450,447) $(584,268)
          
    Net loss per shares:     
    Net loss per share attributable to common stockholders - basis and diluted$(0.50) $(0.29)
    Weighted average common shares - basic and diluted 4,868,915  1,981,765





    Gain Therapeutics, Inc

    CONSOLIDATED STATEMENTS OF CASH FLOWS

    (unaudited)

     For Three Months Ended March, 31
      2021  2020 
      USD  USD 
    Operating activities:      
    Net loss$(2,450,447) $(584,268) 
      -    
    Adjustments to reconcile net loss to net cash used in operating activities:    
    Depreciation 3,403  2,101 
    Stock based compensation 110,725  - 
    Changes in operating assets and liabilities:      
    Account receivables and other currents assets (513,738)  62,947 
    Other non current assets (8,075)    
    Account payables and other current liabilities 82,927  (184,920) 
    Tax payable 3,456  (2,355) 
    Pension liability 22,907  8,085 
    Deferred income (61,065)  (54,406) 
    Total changes in operating assets and liabilities (473,588)  (170,649) 
    Net cash used in operating activities$(2,809,907) $(752,816) 
           
    Cash flows from investing activities:      
    Purchase of computers and office equipment (28,488)  (4,897) 
    Net cash used in investing activities $(28,488) $(4,897) 
           
    Cash flow from financing activities:      
    Proceeds from long-term debts -  284,598 
    Proceeds from issuance of Series A Preferred Stock, net of issuance costs -  1,108,097 
    Proceeds from issuance of common shares upon completion of initial public offering, net of offering costs 42,629,998  - 
    Payments of deferred offering costs (639,693)    
    Net cash provided by financing activities$41,990,305 $1,392,695 
    Effect of exchange rate changes (19,904)  (3,573) 
    Net increase in cash, cash equivalents and restricted cash$39,132,006 $631,409 
    Cash, cash equivalents and restricted cash at beginning of period7,504,281  313,700 
    Cash, cash equivalents and restricted cash at end of period$46,636,287 $945,109 
           

    SOURCE: Gain Therapeutics, Inc.

    Investor & Media Contacts:

    Gain Therapeutics Investor Contact:

    Daniel Ferry

    LifeSci Advisors

    +1 (617) 430-7576

    Gain Therapeutics Media Contact:

    Madeline Joanis

    LifeSci Communications

    +1 646-751-4366



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  5. Compounds reverse the neurodegenerative process observed in a Parkinson's disease in vivo model

    Compounds are novel allosteric regulators that bind, stabilize and restore activity of mutated GCase

    Compounds decrease both phosphorylated and aggregated α-synuclein levels in vitro and in vivo

    BETHESDA, Md., May 03, 2021 (GLOBE NEWSWIRE) -- Gain Therapeutics, Inc. (NASDAQ:GANX) ("Gain"), a biotechnology company focused on redefining drug discovery by using super-computational methods to target allosteric binding sites and guide enzymes back to their proper shape, today announced new pre-clinical data from its GBA1 Parkinson's disease program. The findings were highlighted in a presentation at the XXVI International Association of Parkinsonism…

    Compounds reverse the neurodegenerative process observed in a Parkinson's disease in vivo model

    Compounds are novel allosteric regulators that bind, stabilize and restore activity of mutated GCase

    Compounds decrease both phosphorylated and aggregated α-synuclein levels in vitro and in vivo

    BETHESDA, Md., May 03, 2021 (GLOBE NEWSWIRE) -- Gain Therapeutics, Inc. (NASDAQ:GANX) ("Gain"), a biotechnology company focused on redefining drug discovery by using super-computational methods to target allosteric binding sites and guide enzymes back to their proper shape, today announced new pre-clinical data from its GBA1 Parkinson's disease program. The findings were highlighted in a presentation at the XXVI International Association of Parkinsonism and Related Disorders (IAPRD) World Congress, a research conference dedicated to Parkinson's disease and other disorders affecting muscle tone and motor control, being held virtually May 1-4, 2021.

    "These data demonstrate that our Structurally Targeted Allosteric Regulators (STARs) compounds open a new potential approach for direct treatment of GBA1 Parkinson's disease by guiding misfolded forms of the GCase enzyme to their proper shape and restoring enzymatic activity," said Manolo Bellotto, Ph.D., General Manager and President at Gain. "STARs bind to novel allosteric binding sites identified using our proprietary Site-Directed Enzyme Enhancement Therapy (SEE-Tx™) drug discovery platform, stabilize and restore enzymatic activity to misfolded GCase. The restoration of GCase activity results in the depletion of the toxic phosphorylated and aggregated forms of α-synuclein and a reversal of the neurodegenerative process resulting in improved locomotor activity in a Parkinson's disease model in rats. We will continue to further explore the potential of these compounds in Parkinson's disease and α-synucleopathies."

    Ricardo Feldman, Ph.D., Associate Professor of Microbiology and Immunology at the University of Maryland School of Medicine, stated, "Our laboratory is using human induced pluripotent stem cells (iPSC) derived from patients with GD and GBA-associated Parkinson's disease to test the efficacy of the two lead STAR chaperones developed by Gain Therapeutics. Our early studies in iPSC-derived neurons from neuronopathic GD patients show that both STAR compounds, GT-02287 and GT-02329 are very effective in meeting target goals. These include increasing the levels of GCase protein, its transport to the lysosome, and decreasing levels of pathogenic α-synuclein. As the work in our laboratory progresses, we look forward to working with Gain's team to further advance its GBA program."

    Eric I. Richman, Chief Executive Officer, added, "There have been many promising treatments for Parkinson's disease that have not come to fruition. Through partnerships with the Michael J. Fox Foundation and the Silverstein Foundation for Parkinson with GBA, we identified two STAR lead candidates that have the potential to help Parkinson's patients with GBA1 gene mutations as well as patients whose GCase protein is misfolded due to aging cellular processes. Our preclinical data demonstrates that our STAR compounds successfully target protein misfolding rather than treating symptoms of the disease, and we are honored our abstract is recognized as one of the top 10 best abstracts at IAPRD this year."

    Key findings from the presentation are highlighted below. To access the presentation please visit the Publications section of the Gain website.

    Preclinical Development of Brain-Penetrant Structurally Targeted Allosteric Regulators (STARs) for the Treatment of GBA1 Parkinson's Disease and Related α-Synucleopathies

    The presented results highlight data from preclinical cell cultures and rodent models, including rotenone models of Parkinson's disease. STARs bound misfolded forms of GCase trapped in the endoplasmic reticulum (ER) and enhanced the processing from the ER to the lysosome. This improved lysosomal GCase activity restored normal lysosomal and autophagic activity and ultimately decreased α-synuclein levels.

    • Two lead STAR candidates (GT-02287 and GT-02329) were identified using Gain's proprietary SEE-Tx™ drug discovery platform
    • Both STAR compounds stabilized GCase and enhanced its enzymatic activity in human fibroblasts isolated from patients with GBA1-related Gaucher disease, which has a similar genetic profile to Parkinson's disease
    • Both STAR compounds were neuroprotective and lowered α-synuclein pathology in primary rat dopaminergic neurons
    • When delivered orally, GT-02329 successfully penetrated the blood brain barrier and enhanced GCase activity and protein levels in the striatum of wild-type mice
    • GT-02287 reduced α-synuclein accumulation in both cell culture and rat models of Parkinson's disease
    • GT-02287 improved locomotor activity in rats treated with rotenone, a model of Parkinson's disease that reproduces certain features of the human disease

    About SEE-Tx™

    SEE-Tx is the first technology platform exclusively designed to use the 3D structure of proteins to systematically identify allosteric binding sites never described previously and predict their druggability. Powered by supercomputers, its novel algorithm orchestrates molecular modeling at a speed and efficiency that has the potential to redefine drug discovery.

    About Gain Therapeutics, Inc.

    Gain Therapeutics, Inc. is redefining drug discovery with its SEE-Tx™ target identification platform. By identifying and optimizing allosteric binding sites that have never before been targeted, Gain is unlocking new treatment options for difficult-to-treat disorders characterized by protein misfolding. Gain was established in 2017 with the support of its founders and institutional investors. It has been awarded funding support from The Michael J. Fox Foundation for Parkinson's Research (MJFF) and The Silverstein Foundation for Parkinson's with GBA, as well as from the Eurostars-2 joint program with co-funding from the European Union Horizon 2020 research and Innosuisse. In July 2020, Gain Therapeutics, Inc. completed a share exchange with Gain Therapeutics, SA, a Swiss corporation, whereby GT Gain Therapeutics SA became a wholly owned subsidiary of Gain Therapeutics, Inc.

    Forward-Looking Statements

    Any statements in this release that are not historical facts may be considered to be "forward-looking statements." Forward-looking statements are based on management's current expectations and are subject to risks and uncertainties which may cause results to differ materially and adversely from the statements contained herein. Such statements include, but are not limited to, statements regarding the market opportunity for Gain's product candidates; and the business strategies and development plans of Gain. Some of the potential risks and uncertainties that could cause actual results to differ from those expected include Gain's ability to: make commercially available its products and technologies in a timely manner or at all; enter into other strategic alliances, including arrangements for the development and distribution of its products; obtain intellectual property protection for its assets; accurately estimate its expenses and cash burn and raise additional funds when necessary. Undue reliance should not be placed on forward-looking statements, which speak only as of the date they are made. Except as required by law, Gain does not undertake any obligation to update any forward-looking statements to reflect new information, events or circumstances after the date they are made, or to reflect the occurrence of unanticipated events.

    Gain Therapeutics Investor Contact:

    Daniel Ferry

    LifeSci Advisors

    +1 617-430-7576

    Gain Therapeutics Media Contact:

    Madeline Joanis

    LifeSci Communications

    +1 646-751-4366

     



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